Bio Pharma Dive
FEBRUARY 25, 2021
Tal Zaks, the biotech's chief medical officer for the past six years, will depart in September after playing a high-profile role in the company's coronavirus vaccine development.
World of DTC Marketing
FEBRUARY 25, 2021
SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?” Drug facts boxes are needed, but the FDA disagrees. According to the AMA one of the key reasons for non-adherence is that patients may be frightened of potential side effects.
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Bio Pharma Dive
FEBRUARY 25, 2021
Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed.
Pharma Mirror
FEBRUARY 25, 2021
Borja Guerra has been appointed new Sales & Service Director of Romaco Kilian in Cologne. The Romaco facilities in Bologna and Karlsruhe likewise have new Sales Directors: Massimiliano Cesarini and Ralph Augenstein. Romaco Kilian GmbH in Cologne has acquired a new Sales & Service Director. As of February 2021, Borja Guerra is responsible not only for the Sales & Service department but also for product and project management at the manufacturer of tablet presses for the pharmaceutical
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
FEBRUARY 25, 2021
The deal, which values Pandion Therapeutics at a more than 100% premium, would hand Merck a drug in early-stage testing for ulcerative colitis and lupus.
pharmaphorum
FEBRUARY 25, 2021
Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. Maryland, US-based company Altimmune is among the biotechs and research labs trying to find more convenient alternatives and believes a nasal vaccine spray that is stable at room temperature could be the answer.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
FEBRUARY 25, 2021
The U.S. FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping.
BioPharma Reporter
FEBRUARY 25, 2021
A program at the University Hospital of TÃbingen is the first in Germany to use whole genome sequencing (WGS) to improve the diagnosis of rare diseases and hereditary cancers.
NY Times
FEBRUARY 25, 2021
Many scientists are expecting another rise in infections. But this time the surge will be blunted by vaccines and, hopefully, widespread caution. By summer, Americans may be looking at a return to normal life.
XTalks
FEBRUARY 25, 2021
Long before the COVID-19 pandemic, many have made the case for going vegetarian , not only to reduce animal suffering, benefit the environment or lead a healthier life, but also for the economic value. With millions of Americans temporarily laid off or unemployed, many are turning to a “rice and beans” diet during this recession. Prior to the most recent economic downturn, misconceptions have existed that plant-based or vegetarian diets are too expensive for the average American, specifically fo
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
FEBRUARY 25, 2021
How has rare disease care changed over the last few years? And what might we expect from the next five? We attended the Rare Disease Day Virtual Parliamentary Event to find out. The rare disease community has a golden opportunity to transform the way care is delivered across all four UK nations – that’s according to speakers at a parliamentary reception held to mark 2021’s Rare Disease Day.
BioPharma Reporter
FEBRUARY 25, 2021
Modernaâs variant-specific vaccine â designed to tackle the South Africa variant â has been shipped to the US National Institutes of Health (NIH) for a Phase 1 clinical trial.
Pharma Times
FEBRUARY 25, 2021
The prestigious Clinical Researcher of the Year – The Americas has now opened its doors for entry, continuing the successes of the 10th anniversary last year.
pharmaphorum
FEBRUARY 25, 2021
To help pharma companies understand what life is really like for patients with a rare disease, a new resource has been released to coincide with Rare Disease Day 2021. A series of stakeholder interviews have been collected in a new video from Bedrock Healthcare Communications and Origins Insights that explores the underappreciated challenges of living with a rare disease.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Drug Patent Watch
FEBRUARY 25, 2021
Annual Drug Patent Expirations for JORNAY+PM Jornay Pm is a drug marketed by Ironshore Pharms and is included in one NDA. There are eleven patents protecting this drug. JORNAY PM…. The post New patent for Ironshore Pharms drug JORNAY PM appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
FEBRUARY 25, 2021
The Silicon Therapeutics acquisition is designed to complement Roivant’s targeted protein degradation platform.
Scienmag
FEBRUARY 25, 2021
Nuclear physicists crank up the energy to put the squeeze on the proton and its quarks Credit: DOE’s Jefferson Lab While protons populate the nucleus of every atom in the universe, sometimes they can be squeezed into a smaller size and slip out of the nucleus for a romp on their own. Observing these squeezed […].
BioSpace
FEBRUARY 25, 2021
The world’s first legal research and cultivation facility dedicated exclusively to psilocybin-producing mushrooms (called shrooms or magic mushrooms) and other plant-based psychedelics recently opened in Jamaica.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
BioPharma Reporter
FEBRUARY 25, 2021
Pfizer and BioNTech have begun evaluating the safety and immunogenicity of a third dose of their mRNA vaccine, to understand the effect of a booster on immunity against current and emerging virus variants.
BioSpace
FEBRUARY 25, 2021
Funds will be used to support the development of its lead asset, AB-101, an ADCC enhancer NK-cell therapy for use in combination with monoclonal antibodies or innate-cell engagers.
pharmaphorum
FEBRUARY 25, 2021
Otsuka and Click Therapeutics are working with Verily, the healthcare subsidiary of Google owners Alphabet, on a fully remote clinical trial testing a digital therapy as an add-on in adults with severe depression. Otsuka is on a mission to develop digital technology to treat mental illness and broke new ground by marketed Abilify Mycite (aripiprazole) a “digital pill” for schizophrenia with Proteus Therapeutics that failed to capture the imagination of payers in the US and proved to be a commerc
BioSpace
FEBRUARY 25, 2021
After announcing a successful primary endpoint in November, AstraZeneca and Amgen presented the full data on their severe asthma antibody candidate on Friday.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Outsourcing Pharma
FEBRUARY 25, 2021
An executive from the rare disease technology solutions company discusses how forcing connections with patients can boost research into such conditions.
BioSpace
FEBRUARY 25, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
pharmaphorum
FEBRUARY 25, 2021
Merck & Co/MSD has agreed to buy Pandion for $1.85 billion, bolting on a pipeline of drugs for autoimmune and other immunological disorders headed by interleukin-2 (IL-2) based therapy PT-101. . The $60 per share is a handsome, more than 100% premium on Pandion’s closing share price yesterday, and gives Merck a foothold in the hot area of treating disease by modifying the activity of regulatory T cells, or Tregs.
Outsourcing Pharma
FEBRUARY 25, 2021
The deal consolidates two significant players in the contract research organization arena, in a deal reportedly worth approximately $12b USD.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Scienmag
FEBRUARY 25, 2021
New flexible X-ray sensor suitable for next-generation medical and industrial applications Credit: Ou Xiangyu X-ray imaging is widely used in areas such as healthcare and forensic science, but existing X-ray machines are unable to capture curved three-dimensional (3D) objects at high resolution, and they are also relatively expensive. Now, an international team of researchers led […].
Pharma Times
FEBRUARY 25, 2021
Production site in Måløv, Denmark manufactures products for oral diabetes treatment Rybelsus
Scienmag
FEBRUARY 25, 2021
Credit: Photo by Brutus Östling Large carnivores are generally sensitive to ecosystem changes because their specialized diet and position at the top of the trophic pyramid is associated with small population sizes. This in turn leads to lower genetic diversity in top predators compared to animals lower down the food chain. Genetic diversity is very […].
pharmaphorum
FEBRUARY 25, 2021
Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is targeting. In a statement, Pfizer said the FDA has granted a fast review for TicoVac tick-borne encephalitis (TBE) vaccine, to prevent the disease in individuals one year of age or older. If approved TicoVac would be the first shot to help protect adults and children who are visiting or living in areas where TBE is endemic.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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